Royalty Report: Drugs, Cancer, Diagnostic – Collection: 385707

License Grant

The Parties have previously entered into several Material Transfer Agreement(s) (MTA) to evaluate certain Licensor compounds under the following three catagories Selective Estrogen Receptor Modulators (SERMs), Hedgehog (HH) Antagonists, and Glucocorticoid Receptor (GR) Agonists, herein referred to as the Compounds. This Agreement shall replace any prior MTAs, as they relate to these Compounds.  Provided however that, SERM Tool Compounds referred to in the SERM MTA shall remain covered under the existing SERM MTA. In addition, the Parties may mutually agree, from time to time, to add additional compounds.

Licensor grants an exclusive license to the Licensed Compounds under the Licensed Patents and Licensed Know-How to research, develop, have developed, make, have made, use, have used, manufacture, have manufactured, register, have registered, offer for sale, sell, have sold, import and export, distribute, and market Licensed Products in the Field within the Territory.  Licensee shall have the right to sublicense.

Licensee shall have an exclusive option to license exclusively the rights related to such Compound in the Field under a separate, definitive license agreement.

License Property

The compounds relate to Selective Estrogen Receptor Modulators (SERMs); Hedgehog (HH) Antagonists; and, Glucocorticoid Receptor (GR) Agonists.

The Licensors Compounds considered and/or evaluated by Licensee under the Agreement and are selected by Licensee to be licensed, the Licensed Compounds.

An Early Preclinical Compound shall be defined as a Compound for which there is less than 4-week GLP toxicology studies in at least two animal species, including at least one rodent species and one  non-rodent species.

A Late Preclinical Compound shall be defined as a Compound for which there is at least 4-week GLP toxicology studies in at least two animal species, including at least one rodent species and one non-rodent species, but no human clinical data.

A Clinical Compound shall be defined as a Compound for which there is at least 4-week GLP toxicology studies in at least two animal species, including at least one rodent species and one non-rodent species, and at least one human clinical study conducted under a US IND or equivalent, and covering at least twenty-eight days of daily dosing.

The licensed patents are all existing and future patents and patent applications relating to the Licensed Compounds.

The licensed products are any pharmaceutical formulation which contains a Licensed Compound for use in the Field, including any metabolites, salts, isomers, or pro-drugs of a Licensed Compound.

Field of Use

The Collaboration agreement and  is to develop and commercialize preclinical compounds discovered by Licensor for dermatologic therapeutics.

The field of use is Diagnostic uses, topical treatments for cosmetic uses and topical treatments for the prevention, amelioration, or cure of dermatological diseases, including without limitation, skin cancers, and conditions in humans and animals.

License Grant

Licensor grants the exclusive license, with the full rights to grant sublicenses through multiple tiers, under the Licensor Know-How and Licensor Patents to research, have researched, develop, have developed, make, have made, use, have used, manufacture, have manufactured, register, have registered, offer for sale, sell, have sold, import and export, distribute, and market Licensed Compounds and Licensed Products in the Field in the Territory.

License Property

Licensor owns and controls intellectual property rights and proprietary information comprising, covering or relating to certain proprietary compounds that have activity against the vitamin D receptor.

Licensed Compound means any of the compounds listed, which are owned by and proprietary to Licensor, and any Additional Compound that is added to the Agreement as a Licensed Compound by Licensee’s proper exercise of the Additional Compound Option.

Licensed Product means any pharmaceutical product that contains a Licensed Compound, which term shall include any dosages, formulations or modes of administration of such product and any metabolites, salts, isomers, or pro-drugs of such product or Licensed Compound.

The licensed compounds are Licensor 2108491, 2108493, 2109866, 2109864, 2l58274, 2159506, 2120588, 608683, 627345, and, 627344.

Additional VDRM Compounds are 2049661, 2140039, 2150701, 2150706, 2178774, 2178821, and, 2178824.

Field of Use

The rights are to dermatology compound.

The Field means all applications that may be of utility for the diagnosis, prevention or treatment of dermatological diseases and conditions, or for other dermatological uses, in humans and animals.

License Grant

Licensor grants an exclusive, worldwide, non-transferable, license, with the right to sublicense, under the Licensor Patent Rights and Know-How to make, use, including in activities directed at the research and Development of Licensed Compounds, have made, sell, have sold, offer to sell, export, import and otherwise exploit or Commercialize Licensed Compounds and Licensed Products in the Field in the Territory.

Licensor grants a non-transferable, non-exclusive license, with the right to sublicense, under the Licensor Other Patent Rights solely to the extent reasonably necessary to make, use (including in activities directed at the research and Development of Licensed Compounds), have made, sell, offer to sell, export and import and otherwise exploit or Commercialize Licensed Compounds and Licensed Products in the Field in the Territory.

License Property

MS564929 Toxicology Studies means the two (2) toxicology reports due n the IND covering the BMS compound designated BMS564929, specifically the 6 onth oral toxicology studies in rats and dogs.

6,670,386 – Bicyclic modulators of androgen receptor function

The licensed compounds and patents relate to controlling various diseases and cancers.

Field of Use

The Field means the diagnosis, prevention, treatment or control of any human or animal disease, disorder or condition, excluding the prevention, treatment or control of any human or animal hyperproliferative disease, disorder or condition. For purposes of clarity, hyperproliferative diseases, disorders and conditions are those diseases, disorders or conditions which are characterized by an abnormal increase in the proliferation or accumulation of cells and include conditions such as cancers and benign hyperplasia, but not diseases, disorders or conditions incident to an abnormal increase in the proliferation or accumulation of cells.

License Grant

Licensor grants to Licensee of the Cayman Islands an exclusive, right and license under the Fablyn Technology to make, have made, use, sell, have sold, import and export Products in the Field in the Territory.

License Property

Licensor owns or has rights under certain patent rights and know-how which relate to Fablyn.

Fablyn means lasofoxifene tartrate.  Fablyn (lasofoxifene tartrate) is a selective estrogen receptor modulator (SERM) intended for the treatment of osteoporosis in postmenopausal women.

Field of Use

Fablyn (lasofoxifene) is a selective estrogen receptor modulator (SERM) that was approved in the EU in 2009 for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.